21 C.F.R. § 520.445b Chlortetracycline powder (chlortetracycline hydrochloride or chlortetracycline bisulfate).
Title 21 - Food and Drugs
(a) Specifications. Chlortetracycline powder contains not less than 15 milligrams per gram chlortetracycline hydrochloride, or chlortetracycline bisulfate equivalent to 25.6, 64 or 102.4 grams per pound (56.4, 141 or 225.6 milligrams per gram) chlortetracycline hydrochloride. (b) Sponsors. See No. 048164 in §510.600(c) of this chapter for conditions of use as in paragraph (d) of this section; No. 053501 for conditions of use as in paragraph (d)(4) of this section; No. 000010 for conditions of use as in paragraphs (d)(4)(i)(A) and (B) and (d)(4)(ii) through (iv) of this section; Nos. 017519 and 059130 for conditions of use as in paragraphs (d)(4)(i)(A) and (B) and (d)(4)(ii) and (iii) of this section. (c) Related tolerances. See §556.150 of this chapter. (d) Conditions of use. (1) Use as chlortetracycline hydrochloride in drinking water as follows: (i) Swine—(A) Amount. Ten milligrams per pound of body weight daily in divided doses. (1) Indications for use. Control and treatment of bacterial enteritis (scours) caused by Escherichia coli and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae (Hemophilus spp.), and Klebsiella spp. $(2) Limitations. Prepare a fresh solution twice daily; as sole source of chlortetracycline; administer for not more than 5 days. (B) [Reserved] (ii) [Reserved] (2) Use as chlortetracycline hydrochloride in a drench or drinking water as follows: (i) Calves—(A) Amount. Ten milligrams per pound of body weight daily in divided doses. (1) Control and treatment of bacterial enteritis (scours) caused by E. coli and bacterial pneumonia (shipping fever) associated with Pasteurella spp., A. pleuropneumoniae (Hemophilus spp.), and Klebsiella spp. (2) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; administer for not more than 5 days; do not slaughter animals for food within 24 hours of treatment; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. (B) [Reserved] (ii) [Reserved] (3) [Reserved] (4) The following uses of chlortetracycline hydrochloride or chlortetracycline bisulfate in drinking water or drench were reviewed by the National Academy of Sciences/National Research Council (NAS/NRC) and found effective: (i) Chickens—(A) Amount. 200 to 400 milligrams per gallon. (1) Indications for use. Control of infectious synovitis caused by Mycoplasma synoviae. (2) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment; do not use in laying chickens. (B) Amount. 400 to 800 milligrams per gallon. (1) Indications for use. Control of chronic respiratory disease and air-sac infections caused by M. gallisepticum and E. coli. (2) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment; do not use in laying chickens. (C) Amount. One thousand milligrams per gallon. (1) Indications for use. Control of mortality due to fowl cholera caused by Pasteurella multocida susceptible to chlortetracycline. $(2) Limitations. See paragraph (d)(4)(i)(A)(2) of this section. (ii) Growing turkeys—(A) Amount. 400 milligrams per gallon. (1) Indications for use. Control of infectious synovitis caused by M. synoviae. (2) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment. (B) Amount. 25 milligrams per pound of body weight daily. (1) Indications for use. Control of complicating bacterial organisms associated with bluecomb (transmissible enteritis, coronaviral enteritis). (2) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 14 days; do not slaughter animals for food within 24 hours of treatment. (iii) Swine—(A) Amount. 10 milligrams per pound body weight daily in divided doses. (B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. and bacterial pneumonia associated with Pasteurella spp., Actinobacillus pleuropneumoniae (Hemophilus spp.), and Klebsiella spp. (C) Limitations. Prepare fresh solution daily; as sole source of chlortetracycline; do not use for more than 5 days; for 000010 and 017519 do not slaughter animals for food within 5 days of treatment; for 053501 do not slaughter animals for food within 24 hours of treatment. (iv) Calves, beef cattle, and nonlactating dairy cattle—(A) Amount. 10 milligrams per pound daily in divided doses. (B) Indications for use. Control and treatment of bacterial enteritis (scours) caused by E. coli and Salmonella spp. and bacterial pneumonia (shipping fever complex) associated with Pasteurella spp., A. pleuropneumoniae (Hemophilus spp.), and Klebsiella spp. (C) Limitations. Prepare fresh solution daily; use as a drench; as sole source of chlortetracycline; do not use for more than 5 days; do not slaughter animals for food within 24 hours of treatment; do not use in lactating cattle; do not administer this product with milk or milk replacers; administer 1 hour before or 2 hours after feeding milk or milk replacers; a withdrawal period has not been established in preruminating calves; do not use in calves to be processed for veal. [57 FR 37324, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992; 58 FR 61015, Nov. 19, 1993; 59 FR 39439, Aug. 3, 1994; 60 FR 26827, May 19, 1995; 60 FR 47052, Sept. 11, 1995; 62 FR 27691, May 21, 1997; 62 FR 35076, June 30, 1997; 62 FR 60656, Nov. 12, 1997; 64 FR 37673, July 13, 1999; 65 FR 10706, Feb. 29, 2000; 66 FR 35898, July 10, 2001; 67 FR 78355, Dec. 24, 2002; 69 FR 62406, Oct. 26, 2004]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.445b Chlortetracycline powder (chlortetracycline hydrochloride or chlortetracycline bisulfate).
